Team-Based Home Blood Pressure Monitoring

NCT05488795 | Active Not Recruiting DMC

• 2 other identifiers: RSRB 6036R33HL157643
• Study Type: interventional
• Target: 5,760
• Locations: 1 country
• Sites: 1

Brief Summary

The overall goal of this study is to identify and rigorously evaluate strategies for implementing and sustaining team-based home blood pressure monitoring (TB-HBPM) within primary care. The TB-HBPM intervention is a multifaceted program involving patient transmission of blood readings to EHR and clinical decision support. Implementation strategies include group-based education on hypertension measurement, target blood pressure goals, drug and lifestyle management, referral to community resources, and team training designed to optimize the coordination of hypertension care, and monthly audit and feedback reports to teams and clinicians. Hypertension control rates are suboptimal in many primary care practices with persistent racial disparities in control. Team-based home blood pressure monitoring (TB-HPBM) involving patient transmission of their home blood pressure readings in real-time to their clinical team has been shown to improve blood pressure control. There is an urgent need to implement TB-HBPM into practice. The overall objective of this research is to assess implementation strategies that mitigate barriers and leverage facilitators to TB-HBHM on hypertension control and disparities between Black and White patients. The study team and investigators will use mixed methods to assess the process and generate knowledge to facilitate broader uptake of TB-HBPM.

Conditions

Hypertension; High Blood Pressure

Keywords

Home blood pressure monitoring; Hypertension control; Primary Care Teams; Implementation Research; Health Equity; Clinical Trial

Outcome Measures

Primary Outcomes (1)

• Blood pressure control

  Change in percent of participants whose BP is controlled (defined as \<140/90 mm Hg) among all eligible patients diagnosed with hypertension based on the last BP reading during the control period and the last BP reading during the follow-up period.

  Up to 48 months participation

Secondary Outcomes (7)

• Blood pressure control by race and ethnicity

  Up to 48 months participation

• Blood pressure control by insurance

  Up to 48 months participation

• Participation in Home Blood Pressure Monitoring (HBPM)

  Beginning of the intervention for the relevant wedge up to 48 months participation

• Transmission of home blood pressure readings

  First three months following each participant's enrollment in HBPM

• Chronic disease self-management capacity (QICA)

  Pre-intervention and six months post-intervention

Other Outcomes (8)

• Clinician mean blood pressure (BP) goal (mm Hg) for patients

  Up to 48 months participation

• Anti-hypertensive medication intensification

  Up to 48 months participation

• The percentage of participants who are managed by a clinical pharmacist

  Up to 48 months participation

Study Arms (3)

Suite TB-HBPM pre intervention

OTHER

Each suite/cluster throughout the institution will begin in the baseline usual care phase in the first year.

Behavioral: Team-Based Home Blood Pressure Monitoring

Suite TB-HBPM throughout intervention implementation

OTHER

Each suite will be randomized to implement the TB-HBPM program during one of three wedges separated by six months between each, 1.5 years later.

Behavioral: Team-Based Home Blood Pressure Monitoring

Suite TB-HBPM post intervention implementation

OTHER

Post implementation phase of the suites 2 years after introduction of intervention.

Behavioral: Team-Based Home Blood Pressure Monitoring

Interventions

Team-Based Home Blood Pressure Monitoring BEHAVIORAL

Implementation of best practices for hypertension control using a practice wide team-based home blood pressure monitoring intervention

Suite TB-HBPM post intervention implementation; Suite TB-HBPM pre intervention; Suite TB-HBPM throughout intervention implementation

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Current HFM patient 18-85 years of age with hypertension diagnosis
• Diagnosis of hypertension based on ICD-10 codes of I10-I14
• at least one HFM health visit and hypertension diagnosis beginning no later than 7/1/2021.

You may not qualify if:

• Not current patient in the participating practices
• Diagnosis of dementia, end-stage renal disease, and/or in hospice
• Currently pregnant

Sponsors & Collaborators

• University of Rochester: lead
• National Institutes of Health (NIH): collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Highland Family Medicine

Rochester, New York, 14620, United States

Location

Related Publications (1)

• Fiscella KA, Sass E, Sridhar SB, Maguire JA, Lashway K, Wong G, Thien A, Thomas M, Bisognano JD, Rosenberg T, Sanders MR, Johnson BA, Polgreen LA. Team-based home blood pressure monitoring for blood pressure equity a protocol for a stepped wedge cluster randomized trial. Contemp Clin Trials. 2023 Nov;134:107332. doi: 10.1016/j.cct.2023.107332. Epub 2023 Sep 16.

  PMID: 37722482 DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Kevin Fiscella, MD, MPH

  URMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Family Medicine

Model Details: Stepped Wedge Cluster Randomized Design. Each practice suite represents a cluster. All eight suites begin in the control group and then cross over (one-way) to the intervention group at one of three randomly assigned time periods, ensuring that all suites eventually receive implementation of TB-HBPM.

Study Record Dates

• First Submitted: July 6, 2022
• First Posted: August 5, 2022
• Study Start: October 1, 2022
• Primary Completion: December 31, 2025
• Study Completion (Estimated): August 31, 2026
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: No personally identifiable information will be transcribed. The de-identified data will be stored in a password-protected file on a secure URMC shared drive housed in the Department of Family Medicine. Only the research team will have access to the de-identified data. 7 years after the completion of the study, the audio recordings will destroyed.

Locations

US (1)